POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK— 510(k) K123328
Substantially EquivalentNitrilist Gloves Manufacturing Sdn Bhd
FDA 510(k) clearance K123328 for POWDER FREE NITRILE EXAMINATION GLOVES, BLUE AND BLACK, Substantially Equivalent on 2013-01-18. Applicant: Nitrilist Gloves Manufacturing Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Nitrilist Gloves Manufacturing Sdn Bhd
- Product code
- Product code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kuala Pilah, MY
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More clearances from Nitrilist Gloves Manufacturing Sdn Bhd
view allAdverse events under product code LZA
product code LZA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.